JP2017500154A - MRI-safe tachycardia lead - Google Patents
MRI-safe tachycardia lead Download PDFInfo
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- JP2017500154A JP2017500154A JP2016542717A JP2016542717A JP2017500154A JP 2017500154 A JP2017500154 A JP 2017500154A JP 2016542717 A JP2016542717 A JP 2016542717A JP 2016542717 A JP2016542717 A JP 2016542717A JP 2017500154 A JP2017500154 A JP 2017500154A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N1/0563—Transvascular endocardial electrode systems specially adapted for defibrillation or cardioversion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
- A61N1/0558—Anchoring or fixation means therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N1/057—Anchoring means; Means for fixing the head inside the heart
- A61N1/0573—Anchoring means; Means for fixing the head inside the heart chacterised by means penetrating the heart tissue, e.g. helix needle or hook
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R43/00—Apparatus or processes specially adapted for manufacturing, assembling, maintaining, or repairing of line connectors or current collectors or for joining electric conductors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
- A61N1/086—Magnetic resonance imaging [MRI] compatible leads
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
- Y10T29/49117—Conductor or circuit manufacturing
Abstract
医療装置リードはリード本体上に配置された管状導体要素を備える。管状導体要素は少なくとも１つのセグメントを含み、そのセグメントは、セグメントの少なくとも１つの電気的性質、例えば電気インピーダンスに影響を与えるように、所定の形態でセグメント内に半径方向に形成された１つ以上の切れ込みを有する。セグメントは医療装置リードのショック導体を形成し得る。これに代わって、管状導体要素は、半径方向に形成された１つ以上の切れ込みをそれぞれ有する近位セグメント、中間セグメント、および遠位セグメントを含んでもよい。近位セグメントおよび中間セグメントの各々における１つ以上の切れ込みは、これらのセグメントが遠位セグメントより高い電気インピーダンスをそれぞれ有するように構成されている。管状導体要素の近位セグメントおよび中間セグメントが外部供給源からの電磁エネルギーをフィルタリングするように作用可能であるように、近位セグメントおよび中間セグメント上には絶縁材の層が配置されている。The medical device lead includes a tubular conductor element disposed on the lead body. The tubular conductor element includes at least one segment, the segment being one or more radially formed within the segment in a predetermined form so as to affect at least one electrical property of the segment, eg, electrical impedance. Has a notch. The segment may form a shock conductor for the medical device lead. Alternatively, the tubular conductor element may include a proximal segment, an intermediate segment, and a distal segment each having one or more radially formed cuts. The one or more cuts in each of the proximal segment and the intermediate segment are configured such that these segments each have a higher electrical impedance than the distal segment. A layer of insulating material is disposed on the proximal and intermediate segments so that the proximal and intermediate segments of the tubular conductor element are operable to filter electromagnetic energy from an external source.
Description
本発明は植え込み型医療装置およびその製造方法に関する。より具体的には、本発明は、ＭＲＩ適合性医療装置リードおよびＭＲＩ適合性医療装置リードを製造するための方法に関する。 The present invention relates to an implantable medical device and a method for manufacturing the same. More specifically, the present invention relates to MRI compatible medical device leads and methods for manufacturing MRI compatible medical device leads.
慢性疼痛、パーキンソン病、心律動異常のような慢性疾患および／または身体障害性疾患に罹患している患者を治療するためには、一般に様々な医療装置が用いられる。これらの医療装置のうち、患者の体内に一時的または恒久的に植え込まれるものは少ない。そのような医療装置としては、神経刺激装置、心臓ペースメーカー、または植え込み型除細動器（ｉｍｐｌａｎｔａｂｌｅ ｃａｒｄｉｏｖｅｒｔｅｒ−ｄｅｆｉｂｒｉｌｌａｔｏｒ：ＩＣＤ）（総じて植え込み型医療装置（Ｉｍｐｌａｎｔａｂｌｅ Ｍｅｄｉｃａｌ Ｄｅｖｉｃｅ：ＩＭＤ））が挙げられる。 A variety of medical devices are commonly used to treat patients suffering from chronic diseases such as chronic pain, Parkinson's disease, abnormal heart rhythms and / or disabilities. Of these medical devices, few are temporarily or permanently implanted in a patient's body. Such medical devices include a nerve stimulator, a cardiac pacemaker, or an implantable cardioverter-deflator (ICD) (generally an implantable medical device (IMD)).
一般に、ＩＭＤは、植込み型パルス発生器と、心臓と植込み型パルス発生器（ｉｍｐｌａｎｔａｂｌｅ ｐｕｌｓｅ ｇｅｎｅｒａｔｏｒ：ＩＰＧ）との間で信号を伝達するために用いられる電極を備えた１つ以上の導電リードとを備える。一般に、ＩＭＤは患者の身体の胸部に植え込まれる。前記リードはＩＰＧから延びて、１つ以上の心腔を刺激する。前記リードは患者に治療を与えるために用いられ、それぞれ１つ以上の導電ケーブル、電極、および／またはコイルを備える。 In general, an IMD includes an implantable pulse generator and one or more conductive leads with electrodes used to transmit signals between the heart and an implantable pulse generator (IPG). Prepare. Generally, the IMD is implanted in the chest of the patient's body. The lead extends from the IPG and stimulates one or more heart chambers. The leads are used to provide treatment to a patient, each comprising one or more conductive cables, electrodes, and / or coils.
さらに、いくつかの状況において、ＩＭＤを有する患者が核磁気共鳴画像法（Ｍａｇｎｅｔｉｃ Ｒｅｓｏｎａｎｃｅ Ｉｍａｇｉｎｇ：ＭＲＩ）の走査を受ける必要がある場合がある。ＭＲＩは、磁場および高周波（ｒａｄｉｏ ｆｒｅｑｕｅｎｃｙ：ＲＦ）パルスを用いて、患者の体内の様々な解剖学的構造の画像を生成する非侵襲性の画像診断法である。典型的には、ＭＲＩスキャナは、磁石を用いて強力な静磁場を形成し、患者の体内の水素原子の陽子を整合させる。次いで、患者を電磁エネルギーのＲＦパルスに曝露して、前記陽子をそれらの軸線のまわりでスピンさせる。前記ＲＦパルスが除去されると、これらの陽子は、静磁場と整合したそれらの静止状態に戻る傾向にある。ＭＲＩスキャナは、スピンした陽子によって生成された信号を検出し、それらの信号が処理されて画像を形成する。 In addition, in some situations, patients with IMD may need to undergo a Magnetic Resonance Imaging (MRI) scan. MRI is a non-invasive imaging technique that uses magnetic fields and radio frequency (RF) pulses to generate images of various anatomical structures within a patient's body. Typically, MRI scanners use magnets to create a strong static magnetic field that aligns protons of hydrogen atoms in the patient's body. The patient is then exposed to an RF pulse of electromagnetic energy, causing the protons to spin about their axes. When the RF pulse is removed, these protons tend to return to their quiescent state consistent with the static magnetic field. The MRI scanner detects signals generated by the spun protons and these signals are processed to form an image.
ＭＲＩ走査中に、前記ＲＦパルスが患者の体内に植え込まれたリードによって感知されてしまうことがある。ＭＲＩエネルギーから生成される誘導電流を最小限にする改善されたリード設計の必要性がある。 During an MRI scan, the RF pulse may be sensed by a lead implanted in the patient's body. There is a need for an improved lead design that minimizes the induced current generated from MRI energy.
実施例１において、医療装置リードは、リード本体と、導電体と、管状導体要素とを備える。前記リード本体は、近位端部、遠位端部、および前記近位端部と遠位端部との間に延びる導体管腔を有する管状部材を含み、前記管状部材は電気絶縁材から製造されている。前記導電体は、前記導体管腔内において前記管状部材の近位端部から前記管状部材の遠位端部に向かって延在する。前記管状導体要素は、前記リード本体の管状部材上において、その近位端部と遠位端部との間に配置されている。前記管状導体要素は、該要素の電気的性質に影響を与えるように、該要素内に形成された１つ以上の切れ込み（ｋｅｒｆｓ）を有し、前記導電体は前記管状導体要素に電気的に結合されている。 In Example 1, the medical device lead includes a lead body, a conductor, and a tubular conductor element. The lead body includes a tubular member having a proximal end, a distal end, and a conductor lumen extending between the proximal and distal ends, the tubular member being manufactured from an electrically insulating material. Has been. The electrical conductor extends from the proximal end of the tubular member toward the distal end of the tubular member within the conductor lumen. The tubular conductor element is disposed on the tubular member of the lead body between its proximal and distal ends. The tubular conductor element has one or more kerfs formed in the element to affect the electrical properties of the element, and the conductor is electrically connected to the tubular conductor element. Are combined.
実施例２では、実施例１の医療装置リードにおいて、前記１つ以上の切れ込みは、前記管状導体要素を通過する電流がらせん経路に沿って伝わるように、らせんパターンに形成されている。 In Example 2, in the medical device lead of Example 1, the one or more cuts are formed in a spiral pattern so that current passing through the tubular conductor element travels along a spiral path.
実施例３では、実施例１または２の医療装置リードにおいて、前記１つ以上の切れ込みは一定ピッチを有する。
実施例４では、実施例１または２の医療装置リードにおいて、前記１つ以上の切れ込みは可変ピッチを有する。
In Example 3, in the medical device lead of Example 1 or 2, the one or more cuts have a constant pitch.
In Example 4, in the medical device lead of Example 1 or 2, the one or more notches have a variable pitch.
実施例５では、実施例１乃至４のいずれかの医療装置リードにおいて、前記第１セグメントは前記医療装置リードの電極を画定する。
実施例６では、実施例１乃至５のいずれかの医療装置リードにおいて、前記管状導体要素は、第１セグメントと、前記第１セグメントから遠位方向に延びる第２セグメントとを備え、前記１つ以上の切れ込みは、前記第１セグメントおよび前記第２セグメントの電気的性質に影響を与えるように、前記第１セグメントおよび前記第２セグメントの各々に形成されており、前記第１セグメントは前記第２セグメントよりも高い電気インピーダンスを有する。
In Example 5, in the medical device lead of any of Examples 1-4, the first segment defines an electrode of the medical device lead.
In Example 6, in the medical device lead of any of Examples 1 to 5, the tubular conductor element includes a first segment and a second segment extending distally from the first segment, wherein the one The above cuts are formed in each of the first segment and the second segment so as to affect the electrical properties of the first segment and the second segment, and the first segment is the second segment. It has a higher electrical impedance than the segment.
実施例７では、実施例６の医療装置リードは、前記第１セグメント上に配置された絶縁材の層をさらに備える。
実施例８では、実施例６または７の医療装置リードにおいて、前記第１セグメントは、電磁エネルギーの外部供給源の存在下において、前記管状導体要素における誘導電流を抑制するように作用可能である。
In Example 7, the medical device lead of Example 6 further comprises a layer of insulating material disposed on the first segment.
In Example 8, in the medical device lead of Example 6 or 7, the first segment is operable to suppress an induced current in the tubular conductor element in the presence of an external source of electromagnetic energy.
実施例９では、実施例１乃至５のいずれかの医療装置リードにおいて、前記管状導体要素は、第１セグメント、第２セグメント、および第３セグメントを含み、前記第２セグメントは前記第１セグメントから遠位方向に延び、前記第３セグメントは前記第２セグメントから遠位方向に延び、前記１つ以上の切れ込みは、前記第１セグメント、前記第２セグメントおよび前記第３セグメントの各々において形成されており、前記第１セグメントおよび前記第２セグメントの各々における１つ以上の切れ込みは、前記第１セグメントおよび前記第２セグメントが前記第３セグメントよりも高い電気インピーダンスを有するように構成されている。 In Example 9, in the medical device lead of any of Examples 1-5, the tubular conductor element includes a first segment, a second segment, and a third segment, wherein the second segment is from the first segment. Extending in a distal direction, the third segment extending distally from the second segment, and the one or more cuts are formed in each of the first segment, the second segment, and the third segment. And the one or more notches in each of the first segment and the second segment are configured such that the first segment and the second segment have a higher electrical impedance than the third segment.
実施例１０では、実施例９の医療装置リードは、前記管状導体要素の第１セグメントおよび第２セグメントが、電磁エネルギーの外部供給源の存在下において、前記管状導体要素における誘導電流を抑制するように作用可能であるように、前記管状導体要素の第１セグメントおよび第２セグメント上に配置された絶縁材の層をさらに備える。 In Example 10, the medical device lead of Example 9 causes the first and second segments of the tubular conductor element to suppress induced currents in the tubular conductor element in the presence of an external source of electromagnetic energy. And further comprising a layer of insulating material disposed on the first and second segments of the tubular conductor element.
実施例１１では、実施例１０の医療装置リードにおいて、前記管状導体要素の第３セグメントの外面は、第３セグメントがショック電極として作動可能となり得るように絶縁されていない。 In Example 11, in the medical device lead of Example 10, the outer surface of the third segment of the tubular conductor element is not insulated so that the third segment can be operable as a shock electrode.
実施例１２では、実施例９乃至１１のいずれかの医療装置リードにおいて、前記導電体は、前記管状導体要素の第１セグメントと第２セグメントと間の移行部に配置された接続位置において、前記管状導体要素に機械的かつ電気的に結合されている。 In Example 12, in the medical device lead of any of Examples 9 to 11, the conductor is at the connection position disposed at the transition between the first segment and the second segment of the tubular conductor element. It is mechanically and electrically coupled to the tubular conductor element.
実施例１３では、実施例９乃至１１のいずれかの医療装置リードにおいて、前記第１セグメント、前記第２セグメントおよび前記第３セグメントは導体材料の単一チューブから形成されている。 In Example 13, in the medical device lead of any of Examples 9 to 11, the first segment, the second segment, and the third segment are formed from a single tube of conductive material.
実施例１４では、実施例９乃至１１のいずれかの医療装置リードにおいて、前記第１セグメント、前記第２セグメントおよび前記第３セグメントのうちの１つ以上は、導体材料の別個のチューブから形成され、その後に溶接接合によって接合されている。 In Example 14, in the medical device lead of any of Examples 9-11, one or more of the first segment, the second segment, and the third segment is formed from a separate tube of conductive material. Then, it is joined by welding joint.
実施例１５では、実施例９乃至１４のいずれかの医療装置リードにおいて、前記第３セグメントにおける切れ込みは、それぞれ前記管状導体要素のまわりに部分的に周方向に延び、かつ前記第３セグメントの長さに沿って分散した一連の切れ込みを含み、前記第３セグメントにおける各切れ込みは、電流が前記第３セグメントを通る非直線流路をとるようにさせるために、隣接する切れ込みから周方向に偏倚されている。 In Example 15, in the medical device lead of any of Examples 9-14, the cuts in the third segment each partially extend circumferentially around the tubular conductor element and the length of the third segment Including a series of incisions distributed along the length, each incision in the third segment being biased circumferentially from an adjacent incision to cause current to take a non-linear flow path through the third segment. ing.
実施例１６において、医療装置リードは、リード本体と、導電体と、管状導体要素とを備える。前記リード本体は、近位端部および遠位端部、並びに前記近位端部と遠位端部との間に延びる導体管腔を有する管状部材を含み、前記管状部材は電気絶縁材から製造されている。前記導電体は、前記導体管腔内において前記管状部材の近位端部から前記管状部材の遠位端部に向かって延在する。前記管状導体要素は、前記リード本体の管状部材上において、その近位端部と遠位端部との間に配置されている。前記管状導体要素は、第１セグメントと、前記第１セグメントから遠位方向に延びる第２セグメントと、前記第２セグメントから遠位方向に延びる第３セグメントとを含み、前記セグメントの各々は、各セグメントの電気インピーダンスに影響を与えるように、所定の形態でそのセグメント内に半径方向に形成された１つ以上の切れ込みを備える。第１セグメントおよび第２セグメントの各々における１つ以上の切れ込みは、第１セグメントおよび第２セグメントが第３セグメントよりも高い電気インピーダンスを有するように構成され、前記導電体は前記管状導体要素に機械的かつ電気的に結合されている。前記管状導体要素の第１セグメントおよび第２セグメント上には絶縁材の層が配置されている。前記管状導体要素の第１セグメントおよび第２セグメントは、電磁エネルギーの外部供給源の存在下において、前記管状導体要素における誘導電流を抑制するように作用可能である。前記管状導体要素の第３セグメントの外面は、第３セグメントがショック電極として作動可能となり得るように絶縁されていない。 In Example 16, a medical device lead includes a lead body, a conductor, and a tubular conductor element. The lead body includes a tubular member having a proximal end and a distal end, and a conductor lumen extending between the proximal end and the distal end, wherein the tubular member is fabricated from an electrically insulating material. Has been. The electrical conductor extends from the proximal end of the tubular member toward the distal end of the tubular member within the conductor lumen. The tubular conductor element is disposed on the tubular member of the lead body between its proximal and distal ends. The tubular conductor element includes a first segment, a second segment extending distally from the first segment, and a third segment extending distally from the second segment, each of the segments comprising: In order to affect the electrical impedance of the segment, it is provided with one or more notches formed radially in the segment in a predetermined configuration. The one or more cuts in each of the first segment and the second segment are configured such that the first segment and the second segment have a higher electrical impedance than the third segment, and the electrical conductor is mechanically coupled to the tubular conductor element. And electrically coupled. A layer of insulating material is disposed on the first segment and the second segment of the tubular conductor element. The first and second segments of the tubular conductor element are operable to suppress induced currents in the tubular conductor element in the presence of an external source of electromagnetic energy. The outer surface of the third segment of the tubular conductor element is not insulated so that the third segment can be operable as a shock electrode.
実施例１７では、実施例１６の医療装置リードにおいて、前記導電体は、前記管状導体要素の第１セグメントと第２セグメントと間の移行部に配置された接続位置において、前記管状導体要素に機械的かつ電気的に結合されている。 Example 17 is the medical device lead of Example 16, wherein the electrical conductor is mechanically coupled to the tubular conductor element at a connection location disposed at a transition between the first segment and the second segment of the tubular conductor element. And electrically coupled.
実施例１８では、実施例１６または１７のいずれかの医療装置リードにおいて、前記第１セグメントおよび第２セグメントにおける切れ込みは、それらのセグメントの長さに沿って、らせんパターンに形成されている。 In Example 18, in the medical device lead of either Example 16 or 17, the cuts in the first and second segments are formed in a helical pattern along the length of the segments.
実施例１９では、実施例１６乃至１８のいずれかの医療装置リードにおいて、前記第１セグメントにおける切れ込みは、前記第１セグメントの長さに沿って一定のピッチを有する。 In Example 19, in the medical device lead of any of Examples 16-18, the cuts in the first segment have a constant pitch along the length of the first segment.
実施例２０では、実施例１６乃至１９のいずれかの医療装置リードにおいて、前記第２セグメントにおける切れ込みは、前記第２セグメントの長さに沿って一定のピッチを有する。 In Example 20, in the medical device lead of any of Examples 16-19, the cuts in the second segment have a constant pitch along the length of the second segment.
実施例２１では、実施例１６乃至１８のいずれかの医療装置リードにおいて、前記第１セグメントおよび第２セグメントのうちの一方または双方における切れ込みは、各セグメントの長さに沿って変化するピッチを有する。 In Example 21, in the medical device lead of any of Examples 16-18, the cuts in one or both of the first segment and the second segment have a pitch that varies along the length of each segment. .
実施例２２では、実施例２１の医療装置リードにおいて、前記第１セグメントおよび第２セグメントのうちの一方または双方における切れ込みのピッチは、前記結合位置からの距離とともに減少する。 In Example 22, in the medical device lead of Example 21, the pitch of the cuts in one or both of the first segment and the second segment decreases with the distance from the coupling location.
実施例２３では、実施例１６乃至２２のいずれかの医療装置リードにおいて、前記第３セグメントにおける切れ込みは、それぞれ前記管状導体要素のまわりに部分的に周方向に延び、かつ前記第３セグメントの長さに沿って分散した一連の切れ込みを含み、前記第３セグメントにおける各切れ込みは、電流が前記第３セグメントを通る非直線流路をとるようにさせるために、隣接する切れ込みから周方向に偏倚されている。 In Example 23, in the medical device lead of any of Examples 16-22, the cuts in the third segment each partially extend circumferentially around the tubular conductor element and the length of the third segment Including a series of incisions distributed along the length, each incision in the third segment being biased circumferentially from an adjacent incision to cause current to take a non-linear flow path through the third segment. ing.
実施例２４では、実施例１６乃至２３のいずれかの医療装置リードにおいて、前記第１セグメント、前記第２セグメントおよび前記第３セグメントは、導体材料の単一チューブから形成されている。 In Example 24, in the medical device lead of any of Examples 16 to 23, the first segment, the second segment, and the third segment are formed from a single tube of conductive material.
実施例２５では、実施例１６乃至２３のいずれかの医療装置リードにおいて、前記第１セグメント、前記第２セグメントおよび前記第３セグメントのうちの１つ以上は、導体材料の別個のチューブから形成され、その後に溶接接合によって接合されている。 In Example 25, in the medical device lead of any of Examples 16-23, one or more of the first segment, the second segment, and the third segment is formed from a separate tube of conductive material. Then, it is joined by welding joint.
実施例２６において、植込み型医療装置リード用のフィルタ付き電極部品（ｆｉｌｔｅｒｅｄ ｅｌｅｃｔｒｏｄｅ ｃｏｍｐｏｎｅｎｔ）であって、前記フィルタ付き電極部品は、第１セグメントと、前記第１セグメントから遠位方向に延びる第２セグメントと、前記第２セグメントから遠位方向に延びる第３セグメントとを含む管状導体要素を備え、前記セグメントの各々は、各セグメントの電気インピーダンスに影響を与えるように、所定の形態でそのセグメント内に半径方向に形成された１つ以上の切れ込みを備える。前記第１セグメントおよび前記第２セグメントの各々における１つ以上の切れ込みは、前記第１セグメントおよび前記第２セグメントが前記第３セグメントよりも高い電気インピーダンスを有するように構成され、前記管状導体要素は導電体に対して機械的かつ電気的に結合されるように構成されている。 Example 26. A filtered electrode component for an implantable medical device lead, the filtered electrode component comprising a first segment and a second segment extending distally from the first segment And a third segment extending distally from the second segment, each of the segments being in a predetermined form within the segment to affect the electrical impedance of the segment. One or more incisions formed in the radial direction are provided. One or more notches in each of the first segment and the second segment are configured such that the first segment and the second segment have a higher electrical impedance than the third segment, and the tubular conductor element is It is configured to be mechanically and electrically coupled to the conductor.
実施例２７では、実施例２６のフィルタ付き電極部品において、前記第１セグメントおよび前記第２セグメントにおける切れ込みは、それらのセグメントの長さに沿って、らせんパターンに形成されている。 In Example 27, in the electrode part with a filter of Example 26, the cuts in the first segment and the second segment are formed in a spiral pattern along the length of the segments.
実施例２８では、実施例２６または２７のいずれかのフィルタ付き電極部品において、前記第１セグメントおよび前記第２セグメントのうちの一方または双方における切れ込みは、各セグメントの長さに沿って一定のピッチを有する。 In Example 28, in the filter-equipped electrode part of any of Examples 26 or 27, the cuts in one or both of the first segment and the second segment have a constant pitch along the length of each segment. Have
実施例２９では、実施例２７または２８のいずれかのフィルタ付き電極部品において、前記第１セグメントおよび前記第２セグメントのうちの一方または双方における切れ込みは、各セグメントの長さに沿って変化するピッチを有する。 In Example 29, in the electrode part with a filter according to any one of Examples 27 and 28, the notch in one or both of the first segment and the second segment has a pitch that varies along the length of each segment. Have
実施例３０では、実施例２９のフィルタ付き電極部品において、前記第１セグメントおよび前記第２セグメントのうちの一方または双方における切れ込みのピッチは、前記第１セグメントおよび前記第２セグメントのうちの他方からの距離とともに減少する。 In Example 30, in the electrode part with a filter of Example 29, the pitch of the cuts in one or both of the first segment and the second segment is from the other of the first segment and the second segment. Decreases with distance.
実施例３１では、実施例２６乃至３０のいずれかのフィルタ付き電極部品において、前記第３セグメントにおける切れ込みは、それぞれ前記管状導体要素のまわりに部分的に周方向に延び、かつ第３セグメントの長さに沿って分散した一連の切れ込みを含み、第３セグメントにおける各切れ込みは、電流が第３セグメントを通る非直線流路をとるようにさせるために、隣接する切れ込みから周方向に偏倚されている。 In Example 31, in the electrode part with a filter according to any one of Examples 26 to 30, the cut in the third segment partially extends circumferentially around the tubular conductor element, and the length of the third segment. Including a series of incisions distributed along the length, each incision in the third segment being circumferentially offset from an adjacent incision to cause the current to take a non-linear flow path through the third segment. .
実施例３２において、医療装置リード用の電気部品を形成する方法は、管状導体要素を固定具に取り付けることと、１つ以上の切れ込みを、レーザーを用いて、前記管状導体要素の電気的性質に影響を与えるように構成された１つ以上の所定パターンで、前記管状導体要素内に半径方向に切断することとを含む。 In Example 32, a method of forming an electrical component for a medical device lead includes attaching a tubular conductor element to a fixture and using one or more incisions in the electrical properties of the tubular conductor element using a laser. Cutting radially into the tubular conductor element in one or more predetermined patterns configured to influence.
実施例３３では、実施例３２の方法において、１つ以上の切れ込みの切断は、第１パターンの切れ込みを前記管状導体要素の第１長さに沿ったらせん経路に切断することと、第２パターンの切れ込みを前記管状導体要素の第２長さに沿った非らせんパターンに切断することとを含む。 In Example 33, in the method of Example 32, the cutting of one or more cuts includes cutting a first pattern of cuts into a spiral path along a first length of the tubular conductor element; Cutting into a non-spiral pattern along a second length of the tubular conductor element.
実施例３４では、実施例３２または３３のいずれかの方法において、１つ以上の切れ込みの切断は、前記管状導体要素の第１セグメント、第２セグメント、および第３セグメントを画定するために、前記第１パターン、前記第２パターンおよび前記第３パターンの切れ込みを切断することを含み、前記第１パターンおよび前記第２パターンは、前記第１パターンおよび前記第２パターンの他方からの距離とともに減少する可変ピッチをそれぞれ有するらせんパターンであり、前記第３パターンは、前記第１セグメントおよび前記第２セグメントが前記第３セグメントの電気インピーダンスよりも高い電気インピーダンスを有するような非らせんパターンである。 In Example 34, in any of the methods of Examples 32 or 33, the cutting of one or more cuts may include the first segment, the second segment, and the third segment of the tubular conductor element as described above. Cutting the first pattern, the second pattern, and the third pattern, wherein the first pattern and the second pattern decrease with distance from the other of the first pattern and the second pattern. Each of the spiral patterns has a variable pitch, and the third pattern is a non-spiral pattern in which the first segment and the second segment have an electrical impedance higher than that of the third segment.
実施例３５では、実施例３２乃至３４のいずれかの方法において、前記管状導体要素は第１管状導体要素であり、前記方法はさらに、レーザーを用いて、１つ以上の切れ込みを第２管状導体要素の電気インピーダンスに影響を与えるように構成された１つ以上の所定パターンで第２管状導体要素内に半径方向に切断することと、前記第１管状導体要素と前記第２管状導体要素とを機械的かつ電気的に結合させることとを含む。 Example 35 is the method of any one of Examples 32 to 34, wherein the tubular conductor element is a first tubular conductor element, and the method further uses a laser to make one or more cuts into the second tubular conductor. Cutting radially into a second tubular conductor element in one or more predetermined patterns configured to affect the electrical impedance of the element; and the first tubular conductor element and the second tubular conductor element; Mechanically and electrically coupled.
複数の実施形態が開示されているが、本発明のさらに他の実施形態は、当業者には、本発明の例示的実施形態を示し、記載している以下の詳細な説明から明白になるであろう。従って、図面および詳細な説明は、本質的に実例であり、限定するものではないとみなされるべきである。 While multiple embodiments have been disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the present invention. I will. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.
本発明は様々な修正および代替形態に適しているが、例として特定の実施形態を図面に示し、以下で詳細に説明する。しかしながら、本発明は本発明を記載した特定の実施形態に限定するものではない。むしろ、本発明は、添付の特許請求の範囲によって定義される本発明の範囲内にあるすべての変更物、均等物、および代替物に及ぶことを意図する。 While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. However, the invention is not limited to the specific embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.
図１は、右心室１０４、右心房１０６、左心室１０８および左心房１１０を含む患者の心臓１０２に治療を提供する心調律管理（ｃａｒｄｉａｃ ｒｈｙｔｈｍ ｍａｎａｇｅｍｅｎｔ：ＣＲＭ）システム１００の概略図である。ＣＲＭシステム１００は、除細動リードのような医療装置リード１１２と、所望の一連の操作を行うためにリード１１２の近位端部１１６に結合されたパルス発生器１１４とを備える。パルス発生器１１４は、ペーシングおよび／または除細動能力によって心臓１０２に治療を与えるための信号を生成する。様々な実施形態において、パルス発生器１１４は植え込み型除細動器（ｉｍｐｌａｎｔａｂｌｅ ｃａｒｄｉｏｖｅｒｔｅｒ−ｄｅｆｉｂｒｉｌｌａｔｏｒ：ＩＣＤ）である。いくつかの実施形態において、ＣＲＭシステム１００は治療を与えるための複数のリードを備えていてもよい。 FIG. 1 is a schematic diagram of a cardiac rhythm management (CRM) system 100 that provides treatment to a patient's heart 102, including a right ventricle 104, a right atrium 106, a left ventricle 108, and a left atrium 110. The CRM system 100 includes a medical device lead 112, such as a defibrillation lead, and a pulse generator 114 coupled to the proximal end 116 of the lead 112 to perform the desired sequence of operations. The pulse generator 114 generates a signal for providing treatment to the heart 102 with pacing and / or defibrillation capabilities. In various embodiments, the pulse generator 114 is an implantable cardioverter-defibrator (ICD). In some embodiments, the CRM system 100 may include multiple leads for providing therapy.
いくつかの実施形態において、リード１１２は、リード本体１１７、ショック電極１１８、ペーシング／感知電極１２０、および１つ以上の導体（図１では図示せず）を備える。ショック電極１１８は、リード１１２の遠位端部１２２に近接して配置され、少なくとも１つの導体に結合されており、かつ不整脈のような異常が感知または検出された場合に、患者の心臓１０２にショックを与えるように構成されている。電極１２０はリード１１２の遠位端部１２２に配置されており、また電極１２０が患者の心臓１０２を感知し、ペーシングすることを可能にする少なくとも１つの導体に接続されている。前記導体は、心臓１０２によって生成される電気信号をパルス発生器１１４に伝達し、かつペーシングのためにパルス発生器１１４によって生成された電気パルスを心臓１０２に伝達することにより、電極１２０が感知およびペーシングを行うことを可能にする。 In some embodiments, the lead 112 comprises a lead body 117, a shock electrode 118, a pacing / sense electrode 120, and one or more conductors (not shown in FIG. 1). The shock electrode 118 is disposed proximate to the distal end 122 of the lead 112, is coupled to at least one conductor, and is attached to the patient's heart 102 when an abnormality such as an arrhythmia is sensed or detected. It is configured to give a shock. The electrode 120 is disposed at the distal end 122 of the lead 112 and is connected to at least one conductor that allows the electrode 120 to sense and pace the patient's heart 102. The conductor transmits electrical signals generated by the heart 102 to the pulse generator 114, and transmits electrical pulses generated by the pulse generator 114 to the heart 102 for pacing, so that the electrodes 120 sense and Allows pacing to be performed.
例示した実施形態では、リード１１２は右心室１０４に留置されている。しかしながら、他の実施形態では、リード１１２は、心臓１０２の右心房１０６、または右心房１０６および右心室１０４の双方、または左室に植え込まれ得る。様々な実施形態において、２本以上のリード１１２が心臓１０２内において異なる標的部位に留置されてもよい。 In the illustrated embodiment, the lead 112 is placed in the right ventricle 104. However, in other embodiments, the lead 112 can be implanted in the right atrium 106 of the heart 102, or both the right atrium 106 and the right ventricle 104, or the left ventricle. In various embodiments, two or more leads 112 may be placed at different target sites within the heart 102.
パルス発生器１１４は一般に、電気信号を処理および生成するように構成された電源および電子回路を備える。前記電源は、その動作を実施するためにＣＲＭシステム１００に電力を提供するバッテリーを備える。前記電子回路は、記憶、処理などのための構成要素を含んでいてもよい。いくつかの実施形態において、パルス発生器１１４は、患者の胸帯に皮下ポケットを形成することによって植え込まれる。任意で、パルス発生器１１４は、胸腔、腹部、頸部などに植え込むこともできる。 The pulse generator 114 generally comprises a power source and electronic circuitry configured to process and generate electrical signals. The power source includes a battery that provides power to the CRM system 100 to perform its operation. The electronic circuit may include components for storage, processing, and the like. In some embodiments, the pulse generator 114 is implanted by forming a subcutaneous pocket in the patient's chest band. Optionally, the pulse generator 114 can be implanted in the chest cavity, abdomen, neck, etc.
以下の実施形態については、主にＣＲＭシステム１００に関連して説明する。しかしながら、当業者には、それらの実施形態が、深部脳刺激装置、脊髄刺激装置などのような、しかしこれらに限定されない他の植え込み型医療装置とともに用いられてもよいことが容易に分かるであろう。 The following embodiments will be described mainly with reference to the CRM system 100. However, those skilled in the art will readily appreciate that these embodiments may be used with other implantable medical devices such as, but not limited to, deep brain stimulators, spinal cord stimulators, and the like. Let's go.
図２は、一実施形態による図１に示したリード１１２の概略図である。リード１１２は、リード本体１１７、導電体１２６、低電圧導体１２８、管状導体要素１３０、絶縁材の層１３２およびチップ電極１３４を備える。いくつかの実施形態において、管状導体要素１３０は、図２の断面Ａ−Ａに示すように、導電体１２６および低電圧導体１２８を取り囲むリード本体１１７上に配置されている。 FIG. 2 is a schematic diagram of the lead 112 shown in FIG. 1 according to one embodiment. The lead 112 includes a lead body 117, a conductor 126, a low voltage conductor 128, a tubular conductor element 130, a layer of insulating material 132, and a tip electrode 134. In some embodiments, the tubular conductor element 130 is disposed on a lead body 117 that surrounds the conductor 126 and the low voltage conductor 128, as shown in section AA of FIG.
より詳細には、リード本体１１７は絶縁性管状部材１３６を含み、絶縁性管状部材１３６は近位端部（図２では図示せず）、遠位端部１３８、および管状部材１３６の近位端部と遠位端部１３８との間に部分的にまたは全体的に延びる１つ以上の導体管腔（断面Ａ−Ａに図示）を有する。例示した実施形態では、管状部材１３６は、第２導体管腔１４２よりわずかに小さなプロファイルを有する第１導体管腔１４０を画定する。 More particularly, lead body 117 includes an insulative tubular member 136 that is a proximal end (not shown in FIG. 2), a distal end 138, and a proximal end of tubular member 136. One or more conductor lumens (shown in section A-A) extending partially or fully between the section and the distal end 138. In the illustrated embodiment, the tubular member 136 defines a first conductor lumen 140 having a slightly smaller profile than the second conductor lumen 142.
第１導体管腔１４０は導電体１２６を受容するように構成されている。いくつかの実施形態において、導電体１２６は、管状部材１３６の近位端部から遠位端部１３８に向かって延びる高電圧ケーブルまたはワイヤであり得る。導電体１２６は、心臓１０２にショックを与えるために、パルス発生器１１４から高電圧電気信号を伝えるように構成されている（図１参照）。ショックを与えるために、導電体１２６は接続位置１４４において管状導体要素１３０に電気的に接続されている。 The first conductor lumen 140 is configured to receive the conductor 126. In some embodiments, the conductor 126 may be a high voltage cable or wire that extends from the proximal end of the tubular member 136 toward the distal end 138. The conductor 126 is configured to carry a high voltage electrical signal from the pulse generator 114 to shock the heart 102 (see FIG. 1). In order to provide a shock, the conductor 126 is electrically connected to the tubular conductor element 130 at the connection location 144.
いくつかの実施形態において、管状導体要素１３０は、近位セグメント１４６、中間セグメント１４８、および遠位セグメント１５０を含む管状構造物である。様々な実施形態において、近位セグメント１４６および中間セグメント１４８は外部供給源（ＭＲＩ）からの電磁エネルギーをフィルタリングするように作用可能である。遠位セグメント１５０は、心臓１０２にショックを与えるように構成されたショック電極として作動可能である。絶縁材の層１３２は、近位セグメント１４６および中間セグメント１４８が周囲組織にエネルギーを与えることができないように、これらのセグメント上に配置されている。 In some embodiments, the tubular conductor element 130 is a tubular structure that includes a proximal segment 146, an intermediate segment 148, and a distal segment 150. In various embodiments, the proximal segment 146 and the intermediate segment 148 are operable to filter electromagnetic energy from an external source (MRI). The distal segment 150 is operable as a shock electrode configured to shock the heart 102. A layer of insulation 132 is disposed on these segments so that proximal segment 146 and intermediate segment 148 cannot energize surrounding tissue.
様々な実施形態において、リード１１２は、その長さに沿って配置された２つ以上の管状導体要素１３０、遠位管状導体要素、および近位管状導体要素を含んでいてもよい。一例において、遠位に位置する管状導体要素は右心室１０４内に配置され、近位に位置する管状導体要素は右心房１０６または上大静脈内に配置される。それらの２つの管状導体要素は、治療の要件に基づいて、独立して作動されてもよい。 In various embodiments, the lead 112 may include two or more tubular conductor elements 130, a distal tubular conductor element, and a proximal tubular conductor element disposed along its length. In one example, the distally located tubular conductor element is disposed within the right ventricle 104 and the proximally disposed tubular conductor element is disposed within the right atrium 106 or superior vena cava. Those two tubular conductor elements may be actuated independently based on the therapeutic requirements.
第２導体管腔１４２は、低電圧導体１２８のような導体を受容するように構成されている。いくつかの実施形態において、低電圧導体１２８は、リード本体１１７の絶縁性管状部材１３６の遠位端部１３８にあるチップ電極１３４まで延びている。一実施形態において、低電圧導体１２８は、シングルファイラーコイルまたはマルチファイラーコイル導体の形態にあり得る。様々な実施形態において、低電圧導体１２８は、非コイル状導体（例えばマルチストランドケーブルなど）であり得る。低電圧導体１２８は、調律異常を検出するために、心臓１０２の電気的活動のような心臓１０２からの電気信号をパルス発生器１１４に伝達するように構成されている。低電圧導体１２８はまた、パルス発生器１１４から心臓１０２にペーシング信号を伝送してもよい。様々な実施形態において、低電圧導体１２８は、導体内における誘導電流を抑制するために、比較的高いインダクタンスコイルとして構成され得る。いくつかの実施形態において、低電圧導体１２８は、患者の体内にリード１１２を植え込むためのスタイレットまたはガイドワイヤー（図示せず）を受容するように構成された管腔を画定してもよい。 Second conductor lumen 142 is configured to receive a conductor, such as low voltage conductor 128. In some embodiments, the low voltage conductor 128 extends to the tip electrode 134 at the distal end 138 of the insulating tubular member 136 of the lead body 117. In one embodiment, the low voltage conductor 128 may be in the form of a single filer coil or a multi-filer coil conductor. In various embodiments, the low voltage conductor 128 can be a non-coiled conductor (eg, a multi-strand cable, etc.). The low voltage conductor 128 is configured to transmit an electrical signal from the heart 102, such as electrical activity of the heart 102, to the pulse generator 114 to detect rhythm abnormalities. The low voltage conductor 128 may also transmit a pacing signal from the pulse generator 114 to the heart 102. In various embodiments, the low voltage conductor 128 can be configured as a relatively high inductance coil to suppress induced current in the conductor. In some embodiments, the low voltage conductor 128 may define a lumen configured to receive a stylet or guidewire (not shown) for implanting the lead 112 in the patient's body.
低電圧導体１２８の遠位端部に接続されたチップ電極１３４は、心臓１０２によって生成される電気的信号を感知するため、および／またはパルス発生器１１４によって生成されたパルスを伝送することによって心臓１０２をペーシングするために、心臓組織のような組織に接触する。いくつかの実施形態において、チップ電極１３４は、ヘリックススクリューの回転によって組織内に挿入され得るヘリックススクリューのような能動的な固定によって、組織と係合することができる。ヘリックススクリューの回転を行うために、チップ電極１３４は、低電圧導体１２８に機械的に結合されており、次いで低電圧導体１２８はリードの近位端部において回転可能要素（例えばターミナルピン）に機械的に結合されている。そのような状況において、チップ電極１３４は、リード１１２を心臓組織に導通させるとともに固定する。他の実施形態では、チップ電極１３４は、リング電極、ボール状電極などのように、組織に接触することのみによって組織と受動的に係合し得る。 A tip electrode 134 connected to the distal end of the low voltage conductor 128 senses the electrical signal generated by the heart 102 and / or transmits the pulses generated by the pulse generator 114. To pace 102, contact tissue such as heart tissue. In some embodiments, the tip electrode 134 can engage the tissue by active fixation such as a helix screw that can be inserted into the tissue by rotation of the helix screw. To effect helix screw rotation, the tip electrode 134 is mechanically coupled to a low voltage conductor 128 which is then mechanically coupled to a rotatable element (eg, a terminal pin) at the proximal end of the lead. Combined. In such a situation, the tip electrode 134 conducts and secures the lead 112 to the heart tissue. In other embodiments, the tip electrode 134 can passively engage the tissue only by contacting the tissue, such as a ring electrode, a ball electrode, or the like.
いくつかの実施形態において、絶縁材の層１３２および絶縁性管状部材１３６は、シリコーン、ポリテトラフルオロエチレン（ＰＴＦＥ）、エチレンテトラフルオロエチレン（ＥＴＦＥ）、フッ素化エチレンプロピレン（ＦＥＰ）、ポリ塩化ビニル（ＰＶＣ）、ポリエーテルエステル、ポリアミド、ポリエーテルエーテルケトン（ＰＥＥＫ）などのような、しかしこれらに限定されない適当な電気絶縁性の生体適合性材料を用いて形成することができる。いくつかの実施形態において、管状部材１３６、導体管腔１４０，１４２は円形断面を有する。しかしながら、矩形、四角形、三角形、楕円形などのような、しかしこれらに限定されない他の適当な断面形状も企図されてもよい。 In some embodiments, the layer of insulating material 132 and the insulating tubular member 136 are made of silicone, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyvinyl chloride ( PVC), polyetheresters, polyamides, polyetheretherketone (PEEK), etc., but can be formed using a suitable electrically insulating biocompatible material. In some embodiments, tubular member 136, conductor lumens 140, 142 have a circular cross section. However, other suitable cross-sectional shapes such as but not limited to rectangles, squares, triangles, ellipses, etc. may be contemplated.
図３は、（図１のショック電極１１８のような）ショック電極および図１のリード１１２のためのＭＲＩフィルタ構成の概略図である。ショック電極およびＭＲＩフィルタ構成は共に管状導体要素１３０の一部を形成する。示したように、管状導体要素１３０は近位セグメント１４６と、近位セグメント１４６から遠位方向に延びる中間セグメント１４８と、中間セグメント１４８から遠位方向に延びる遠位セグメント１５０とを含む。近位セグメント、中間セグメント、および遠位セグメント１４６、１４８、１５０は、各々、管状導体要素１３０を画定する壁内に半径方向に形成された切れ込みのパターンをそれぞれ含む。前記切れ込みは、管状導体材料１３０の材料を所定パターンに切断（例えばレーザー切断）するか、または他の場合には（例えばエッチングによって）除去することにより形成された溝穴である。いくつかの実施形態では、近位セグメント１４６および中間セグメント１４８はＭＲＩフィルタ構成を構成し、かつ遠位セグメント１５０はショック電極である。 FIG. 3 is a schematic diagram of an MRI filter configuration for a shock electrode (such as shock electrode 118 of FIG. 1) and lead 112 of FIG. Both the shock electrode and the MRI filter configuration form part of the tubular conductor element 130. As shown, tubular conductor element 130 includes a proximal segment 146, an intermediate segment 148 extending distally from proximal segment 146, and a distal segment 150 extending distally from intermediate segment 148. Proximal segment, intermediate segment, and distal segment 146, 148, 150 each include a pattern of cuts formed radially in the wall defining tubular conductor element 130, respectively. The notches are slots formed by cutting the material of the tubular conductor material 130 into a predetermined pattern (eg, laser cutting) or otherwise removing (eg, by etching). In some embodiments, proximal segment 146 and middle segment 148 constitute an MRI filter configuration and distal segment 150 is a shock electrode.
近位セグメント１４６は、近位端部１５２、遠位端部１５４、および近位端部１５２と遠位端部１５４との間に延びるコイル状導体を含む。
図２および図３を参照すると、いくつかの実施形態において、近位セグメント１４６は、導電体１２６におけるＭＲＩ干渉の効果を相殺するために、ＭＲＩ走査中に生成されるＲＦエネルギーから導電体を遮蔽するように構成された伝送線路フィルタとして作用可能である。導電体１２６は、近位セグメント１４６と中間セグメント１４８との間で接続位置１４４において管状導体要素１３０に接続されている。図示したように、近位セグメント１４６の遠位端部１５４は導電体１２６に接続されている。
Proximal segment 146 includes a proximal end 152, a distal end 154, and a coiled conductor that extends between proximal end 152 and distal end 154.
With reference to FIGS. 2 and 3, in some embodiments, the proximal segment 146 shields the conductor from the RF energy generated during the MRI scan to offset the effects of MRI interference on the conductor 126. It is possible to act as a transmission line filter configured as described above. The conductor 126 is connected to the tubular conductor element 130 at a connection location 144 between the proximal segment 146 and the intermediate segment 148. As shown, the distal end 154 of the proximal segment 146 is connected to the conductor 126.
中間セグメント１４８は、ＲＦ脈動磁場（ＲＦ ｐｕｌｓａｔｉｎｇ ｍａｇｎｅｔｉｃ ｆｉｅｌｄ）またはＭＲＩ環境により誘発されたＲＦ信号を調整するか、または阻止する（ｃｈｏｋｅ）ために用いられるインラインチューニングフィルタとして作用可能である。中間セグメント１４８は、（パルス発生器１１４のような）パルス発生器によって生成される電気的信号の流れに影響を与えることなく、特定の周波数に高いインピーダンスをもたらすインダクタンスを有する。ＲＦ信号によりリード１１２において交流電流が誘発されると、中間セグメント１４８のまわりに磁場が生成され、この磁場はさらなる電流の変化に対抗する。これにより、中間セグメント１４８は、リード１１２または導電体１２６内に生成された望ましくない電流または電圧信号を、それらの生成された信号がリード１１２の他の部分、特にショック電極に伝送されないように減衰させることができる。いくつかの実施形態において、近位セグメント１４６および中間セグメント１４８は、６４ＭＨｚ、１２８ＭＨｚ、またはＭＲＩ手順中に必要とされる他の周波数のような異なるＭＲＩ周波数に調整されてもよい。 The intermediate segment 148 can act as an in-line tuning filter that is used to condition or choke RF signals induced by an RF pulsating magnetic field or MRI environment. The intermediate segment 148 has an inductance that provides a high impedance at a particular frequency without affecting the flow of electrical signals generated by a pulse generator (such as pulse generator 114). When an alternating current is induced in the lead 112 by the RF signal, a magnetic field is generated around the intermediate segment 148, which counters further current changes. This causes the intermediate segment 148 to attenuate undesired current or voltage signals generated in the lead 112 or conductor 126 so that those generated signals are not transmitted to other parts of the lead 112, particularly the shock electrode. Can be made. In some embodiments, the proximal segment 146 and the intermediate segment 148 may be tuned to different MRI frequencies, such as 64 MHz, 128 MHz, or other frequencies required during the MRI procedure.
いくつかの実施形態において、近位セグメント１４６および中間セグメント１４８は、残った導体材料もらせん構成で延在するように、管状導体要素１３０の周囲および長さに沿ってらせんパターンに形成された切れ込みを有するように構成および配列されている。様々な実施形態において、ピッチ（すなわち、らせん状に配置された切れ込みの隣接するターンの間の距離）は、近位セグメントおよび／または中間セグメント１４６、１４８の長さに沿ってほぼ均一であり得る。これに代わって、近位セグメントおよび遠位セグメント１４６、１５０のうちの一方または双方は、前記切れ込みのピッチが前記セグメントの長さの全体または一部に沿って変化するように構成されていてもよい。可変ピッチは、近位セグメント１４６および／または中間セグメント１４８の電気的性質を変更し得る。一実施形態において、近位セグメント１４６および中間セグメント１４８は、接続位置１４４付近において、より小さなピッチを有するように構成される。 In some embodiments, the proximal segment 146 and the intermediate segment 148 are notches formed in a spiral pattern along the circumference and length of the tubular conductor element 130 such that the remaining conductor material also extends in a spiral configuration. Are configured and arranged to have In various embodiments, the pitch (ie, the distance between adjacent turns of a spirally arranged cut) can be substantially uniform along the length of the proximal and / or intermediate segments 146, 148. . Alternatively, one or both of the proximal segment and the distal segment 146, 150 may be configured such that the pitch of the notch varies along all or part of the length of the segment. Good. The variable pitch may change the electrical properties of the proximal segment 146 and / or the intermediate segment 148. In one embodiment, the proximal segment 146 and the intermediate segment 148 are configured to have a smaller pitch near the connection location 144.
遠位セグメント１５０は、管状導体要素１３０の遠位部分を形成する。遠位セグメント１５０は、心臓にショックまたは高電圧パルスを与えるように構成されたショック電極として作動可能である。例示した実施形態において、遠位セグメント１５０は、管状導体要素１３０の周囲に部分的に沿って延びる切れ込みを有するように設計されている。遠位セグメント１５０に電気的信号が送信される場合に、前記切れ込みは、エネルギーをより大きな表面積に対して分散させる非直線状の経路をとるように電流を指向し、それにより周囲組織の加熱を最小限にする。 Distal segment 150 forms the distal portion of tubular conductor element 130. Distal segment 150 is operable as a shock electrode configured to deliver a shock or high voltage pulse to the heart. In the illustrated embodiment, the distal segment 150 is designed to have a cut extending partially along the circumference of the tubular conductor element 130. When an electrical signal is transmitted to the distal segment 150, the notch directs the current to take a non-linear path that dissipates energy over a larger surface area, thereby heating the surrounding tissue. Minimize.
様々な実施形態において、管状導体要素１３０は、ニチノール（商標）、金、銀、ステンレス鋼、銅、白金、またはこれらの材料の組み合わせのような、しかしこれらに限定されない、適当な非強磁性導電生体適合性材料を用いて形成することができる。 In various embodiments, the tubular conductor element 130 is a suitable non-ferromagnetic conductive material such as, but not limited to, Nitinol ™, gold, silver, stainless steel, copper, platinum, or combinations of these materials. It can be formed using a biocompatible material.
図４は、導体材料の単一チューブから製造された図１のリード１１２に類似したリード２１２のためのショック電極およびＭＲＩのフィルタ構成の概略図である。例示した実施形態では、管状導体要素２３０は、一体チューブの壁に切れ込みを形成することにより形成された近位セグメント２４６、中間セグメント２４８、および遠位セグメント２５０を含む。導電体２２６は、近位セグメント２４６と中間セグメント２４８との間の接続位置２４４において管状導体要素２３０に機械的かつ電気的に結合されている。 FIG. 4 is a schematic diagram of a shock electrode and MRI filter configuration for a lead 212 similar to the lead 112 of FIG. 1 made from a single tube of conductive material. In the illustrated embodiment, the tubular conductor element 230 includes a proximal segment 246, an intermediate segment 248, and a distal segment 250 formed by making cuts in the wall of the integral tube. The electrical conductor 226 is mechanically and electrically coupled to the tubular conductor element 230 at a connection location 244 between the proximal segment 246 and the intermediate segment 248.
いくつかの実施形態において、（図４の詳細図に示したような）コネクター２５６は導電体２２６を管状導体要素２３０に結合するために用いられる。例示した実施形態において、コネクター２５６は、導電体２２６の遠位端部を受容するように構成されたサドル型部分２５８を備える。導電体２２６は、コネクター２５６のサドル型部分２５８内に配置されて、コネクター２５６に結合される。固定のためには、溶着、はんだ付け、熱接着、圧着（ｃｒｉｍｐｉｎｇ）などの技術が用いられてもよい。いくつかの実施形態において、コネクター２５６は、導電体２２６をコネクター２５６と緊密に固定するように構成されたフラップを備える。固定したら、コネクター２５６は、導電体２２６と共に、管状導体要素２３０内に配置される。次に、コネクター２５６は、溶着、はんだ付けのような、しかしこれらに限定されない適当な技術によって管状導体要素２３０に結合される。いくつかの実施形態において、コネクター２５６は、導電体２２６を管状導体要素２３０に対して電気的に接続する金属リングである。 In some embodiments, a connector 256 (as shown in the detailed view of FIG. 4) is used to couple the conductor 226 to the tubular conductor element 230. In the illustrated embodiment, the connector 256 includes a saddle-shaped portion 258 configured to receive the distal end of the conductor 226. The conductor 226 is disposed within the saddle-shaped portion 258 of the connector 256 and is coupled to the connector 256. For fixing, techniques such as welding, soldering, thermal bonding, and crimping may be used. In some embodiments, the connector 256 includes a flap configured to tightly secure the electrical conductor 226 with the connector 256. Once secured, the connector 256 is placed within the tubular conductor element 230 along with the conductor 226. The connector 256 is then coupled to the tubular conductor element 230 by any suitable technique such as, but not limited to, welding, soldering. In some embodiments, connector 256 is a metal ring that electrically connects conductor 226 to tubular conductor element 230.
さらに、示されているように、近位セグメント２４６および中間セグメント２４８は可変ピッチを有する。いくつかの実施形態において、近位セグメント２４６および中間セグメント２４８における切れ込みのピッチは、接続位置２４４における反射を低減するために、導電体２２６が管状導体要素２３０に接続される接続位置２４４から遠ざかる方向に減少する。 Further, as shown, proximal segment 246 and intermediate segment 248 have a variable pitch. In some embodiments, the pitch of the cuts in the proximal segment 246 and the intermediate segment 248 is a direction away from the connection location 244 where the conductor 226 is connected to the tubular conductor element 230 to reduce reflection at the connection location 244. To decrease.
図５は、導体材料の２本のチューブから製造された図１のリード１１２に類似したリード３１２のためのショック電極およびＭＲＩのフィルタ構成の概略図である。ショック電極およびＭＲＩフィルタ構成は、下記に述べること以外は図４のショック電極およびＭＲＩフィルタ構成とほぼ同様に構成され得る。例示した実施形態において、管状導体要素３３０は、第１チューブ３６０と第２チューブ３６２とを溶接接合において接合することにより形成される。第１チューブ３６０は近位セグメント３４６を含み、第２チューブ３６２は中間セグメント３４８および遠位セグメント３５０を含む。図４のコネクター２５６に類似した、サドル型部分３５８を有するコネクター３５６は、導電体３２６および第２チューブ３６２に結合される。次に、第１チューブ３６０は、導電体３２６上を摺動させられ、第２チューブ３６２に結合されて、管状導体要素３３０を形成する。第１チューブ３６０の第２チューブ３６２への結合は、当業において既知の任意の適当な技術によって行われ得る。例示的な技術としては、溶接、はんだ付け、熱接着などが挙げられる。 FIG. 5 is a schematic diagram of a shock electrode and MRI filter configuration for a lead 312 similar to the lead 112 of FIG. 1 made from two tubes of conductive material. The shock electrode and MRI filter configuration may be substantially similar to the shock electrode and MRI filter configuration of FIG. 4 except as described below. In the illustrated embodiment, the tubular conductor element 330 is formed by joining the first tube 360 and the second tube 362 in a weld joint. The first tube 360 includes a proximal segment 346 and the second tube 362 includes an intermediate segment 348 and a distal segment 350. Similar to the connector 256 of FIG. 4, a connector 356 having a saddle-shaped portion 358 is coupled to the conductor 326 and the second tube 362. The first tube 360 is then slid over the conductor 326 and coupled to the second tube 362 to form the tubular conductor element 330. The coupling of the first tube 360 to the second tube 362 can be performed by any suitable technique known in the art. Exemplary techniques include welding, soldering, thermal bonding, and the like.
図６は、様々な実施形態による、図１のリードのためのショック電極およびＭＲＩフィルタ構成を製造する技術を示す概略図である。例示した実施形態では、ショック電極およびＭＲＩフィルタ構成は、導体材料の単一チューブからのものであり得る。管状導体要素４３０は固定具４６４に取り付けられている。固定具４６４は、所定の方法で、管状導体要素４３０を保持し、回転させるように構成されている。固定具４６４は、管状導体要素４６４の遠位端部および／または近位端部と係合してもよい。 FIG. 6 is a schematic diagram illustrating a technique for fabricating a shock electrode and MRI filter configuration for the lead of FIG. 1 according to various embodiments. In the illustrated embodiment, the shock electrode and MRI filter configuration can be from a single tube of conductive material. Tubular conductor element 430 is attached to fixture 464. The fixture 464 is configured to hold and rotate the tubular conductor element 430 in a predetermined manner. The fastener 464 may engage the distal end and / or the proximal end of the tubular conductor element 464.
さらに、レーザー４６６は、固定具４６４上に取り付けられた管状導体要素４３０上の適所に配備される。レーザー４６６は、高強度光線４６８を生成し、かつ１つ以上の切れ込み４７０を状導体要素４３０内に半径方向に切断するために、横断面において軸線方向に移動するように構成されている。レーザー４６６は、管状導体要素４３０に当たるようになされた高強度光線を発する。光線４６８のエネルギーは管状導体要素４３０に伝えられ、それにより管状導体要素４３０の材料を融解および／または気化させて、切れ込み４７０を形成する。いくつかの実施形態において、レーザー４６６の動作は、レーザー４６６の出力を所定パターンに従わせる自動システムによって制御され得る。 Further, the laser 466 is deployed in place on the tubular conductor element 430 mounted on the fixture 464. Laser 466 is configured to move axially in cross-section to generate high intensity light beam 468 and to radially cut one or more cuts 470 into the conductor element 430. Laser 466 emits a high intensity beam adapted to strike tubular conductor element 430. The energy of the light beam 468 is transferred to the tubular conductor element 430, thereby melting and / or vaporizing the material of the tubular conductor element 430 to form the cut 470. In some embodiments, the operation of laser 466 may be controlled by an automated system that causes the output of laser 466 to follow a predetermined pattern.
様々な実施形態において、切れ込み４７０を形成するためにＣＯ２レーザーが用いられる。切れ込み４７０を形成するために使用することができるレーザー４６６の他の好適な例としては、Ｎｄ−ＹＡＧレーザー、ＹＡＧレーザーなどが挙げられるが、これらに限定されるものではない。これに代わって、いくつかの実施形態では、プラズマ技術を用いて管状導体要素４３０内に切れ込み４７０を形成してもよい。 In various embodiments, a CO 2 laser is used to form the cut 470. Other suitable examples of laser 466 that can be used to form cut 470 include, but are not limited to, Nd-YAG laser, YAG laser, and the like. Alternatively, in some embodiments, plasma technology may be used to form the cut 470 in the tubular conductor element 430.
様々な実施形態において、切れ込み４７０は、管状導体要素４３０の電気的性質に影響を与えるように形成され得る。いくつかの実施形態において、第１パターンの切れ込み４７０（図示せず）は管状導体材料４３０の第１長さに沿って切断され、第２パターンの切れ込み４７０は管状導体要素４３０の第２長さに沿って切断される。第１パターンの切れ込み４７０は、近位セグメントおよび中間セグメントを含む第１長さに沿って形成されたらせん経路を含む。さらに、例示した実施形態では、第２パターンの切れ込み４７０は、第２長さに沿ったらせんパターンまたは非らせんパターンを含み得る。示したように、前記非らせんパターンは、管状導体要素４３０の周囲に沿って部分的に延びるように形成された切断部または溝穴を含む。 In various embodiments, the cut 470 can be formed to affect the electrical properties of the tubular conductor element 430. In some embodiments, a first pattern of cuts 470 (not shown) is cut along the first length of the tubular conductor material 430 and the second pattern of cuts 470 is a second length of the tubular conductor element 430. Is cut along. The first pattern of cuts 470 includes a helical path formed along a first length that includes a proximal segment and an intermediate segment. Further, in the illustrated embodiment, the second pattern cut 470 may include a spiral or non-spiral pattern along the second length. As shown, the non-spiral pattern includes cuts or slots formed to extend partially along the circumference of the tubular conductor element 430.
他の実施形態では、切れ込み４７０は、管状導体要素４３０の異なる部分に沿って画定された第１パターン、第２パターン、および第３パターンの切れ込みを含む。第１パターンは管状導体要素４３０の（近位セグメント１４６に類似した）近位セグメントを画定し、第２パターンは管状導体要素４３０の（中間セグメント１４８に類似した）中間セグメントを画定し、また第３パターンは管状導体要素４３０の（遠位セグメント１５０に類似した）遠位セグメントを画定する。好ましい実施形態において、第１パターンおよび第２パターンは可変ピッチを有するらせんパターンである。前記可変ピッチは、第１パターンおよび第２パターンの他方からの距離に従って減少する。第３パターンは、近位セグメントおよび中間セグメントが遠位セグメントの電気インピーダンスよりも高い電気インピーダンスを有するような非らせんパターンである。 In other embodiments, the cuts 470 include a first pattern, a second pattern, and a third pattern of cuts defined along different portions of the tubular conductor element 430. The first pattern defines a proximal segment (similar to the proximal segment 146) of the tubular conductor element 430, the second pattern defines an intermediate segment (similar to the intermediate segment 148) of the tubular conductor element 430, and The three patterns define the distal segment (similar to distal segment 150) of tubular conductor element 430. In a preferred embodiment, the first pattern and the second pattern are spiral patterns with variable pitch. The variable pitch decreases according to the distance from the other of the first pattern and the second pattern. The third pattern is a non-spiral pattern in which the proximal segment and the intermediate segment have an electrical impedance that is higher than the electrical impedance of the distal segment.
検討した具体例としての実施形態に対して、本発明の範囲から逸脱することなく、様々な変更および追加をなすことができる。例えば、上記に記載した実施形態は特定の特徴に言及しているが、本発明の範囲はまた、特徴の異なる組み合わせを有する実施形態および記載した特徴のすべてを含んでいるとは限らない実施形態も包含する。従って、本発明の範囲は、特許請求の範囲内にあるすべてのそのような代替案、変更例および別例を、それらのすべての均等物と共に、包含するように意図される。 Various changes and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, although the embodiments described above refer to particular features, the scope of the invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Is also included. Accordingly, the scope of the invention is intended to embrace all such alternatives, modifications and variations that fall within the scope of the claims, along with all their equivalents.
Claims (15)
前記導体管腔内において前記管状部材の近位端部から前記管状部材の遠位端部に向かって延在する導電体と、
前記リード本体の管状部材上において、その近位端部と遠位端部との間に配置された管状導体要素であって、前記管状導体要素は、該管状導体要素の電気的性質に影響を与えるように該管状導体要素内に形成された１つ以上の切れ込みを有し、前記導電体は前記管状導体要素に電気的に結合されている、管状導体要素とを備える、医療装置リード。 A lead body comprising a tubular member having a proximal end, a distal end, and a conductor lumen extending between the proximal and distal ends, wherein the tubular member is fabricated from an electrically insulating material. The lead body,
An electrical conductor extending from the proximal end of the tubular member toward the distal end of the tubular member within the conductor lumen;
A tubular conductor element disposed between a proximal end and a distal end on a tubular member of the lead body, the tubular conductor element affecting the electrical properties of the tubular conductor element; A medical device lead comprising: a tubular conductor element having one or more cuts formed in the tubular conductor element to provide, the conductor being electrically coupled to the tubular conductor element.
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| PCT/US2015/017473 WO2015130753A1 (en) | 2014-02-26 | 2015-02-25 | Construction of an mri-safe tachycardia lead |
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2015
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- 2015-02-25 CN CN201580008911.1A patent/CN106029162A/en active Pending
- 2015-02-25 JP JP2016542717A patent/JP6244469B2/en not_active Expired - Fee Related
- 2015-02-25 AU AU2015223154A patent/AU2015223154B2/en not_active Ceased
- 2015-02-25 US US14/631,010 patent/US9504821B2/en not_active Expired - Fee Related
- 2015-02-25 WO PCT/US2015/017473 patent/WO2015130753A1/en active Application Filing
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2016
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Also Published As
| Publication number | Publication date |
|---|---|
| CN106029162A (en) | 2016-10-12 |
| JP6244469B2 (en) | 2017-12-06 |
| US9682231B2 (en) | 2017-06-20 |
| WO2015130753A1 (en) | 2015-09-03 |
| EP3110499A1 (en) | 2017-01-04 |
| AU2015223154B2 (en) | 2017-04-13 |
| AU2015223154A1 (en) | 2016-06-16 |
| US20160361538A1 (en) | 2016-12-15 |
| US9504821B2 (en) | 2016-11-29 |
| US20150238756A1 (en) | 2015-08-27 |
| EP3110499B1 (en) | 2018-01-24 |
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